CTRI

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CTRI Number

CTRI/2018/04/013288 [Registered on: 16/04/2018] Trial Registered Retrospectively

Last Modified On:

09/04/2018

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Other

Public Title of Study

Comparison of two instruments in wisdom tooth removal

Scientific Title of Study

Applications of piezosurgery in disimpaction of mandibular third molars versus conventional ostectomy methods

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Jyotsna Rajan
Designation	Post graduate student
Affiliation	Manipal College Of Dental Sciences, Manipal
Address	Department of oral and maxillofacial surgery, Room no 4, Manipal College of Dental Sciences, Manipal University Udupi KARNATAKA 576104 India
Phone	8310028979
Fax
Email	jyotsnarajan7@gmail.com

Details of Contact Person
Scientific Query

Name	Dr G Srikanth
Designation	ASSOCIATE PROFESSOR
Affiliation	Manipal College Of Dental Sciences, Manipal
Address	Department of oral and maxillofacial surgery, Room no 4, Manipal College of Dental Sciences, Manipal University Udupi KARNATAKA 576104 India
Phone	9986455201
Fax
Email	gadi_mds@rediffmail.com

Details of Contact Person
Public Query

Name	Dr Jyotsna Rajan
Designation	Post graduate student
Affiliation	Manipal College Of Dental Sciences, Manipal
Address	Department of oral and maxillofacial surgery, Room no 4, Manipal College of Dental Sciences, Manipal University Udupi KARNATAKA 576104 India
Phone	8310028979
Fax
Email	jyotsnarajan7@gmail.com

Source of Monetary or Material Support

Manipal college of dental sciences, Manipal University

Primary Sponsor

Name	Not applicable
Address	Not applicable
Type of Sponsor	Other [No monetary support]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Jyotsna Rajan	Manipal College of Dental Sciences	Department of oral and maxillofacial surgery, Room no 4, Manipal College of Dental Sciences, Manipal University, Manipal 576104 Udupi KARNATAKA	8310028979 jyotsnarajan7@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee, Kasturba Medical College	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Impacted lower third molars,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Piezosurgical unit	Piezosurgical unit and blades were used for extraction of third molar, in 10 patients over a period of 1.5 years for this study purpose, to evaluate the efficiency of the same as compared to rotatory instrument.
Comparator Agent	Rotary instrument	Most commonly used electric driven instrument for removal of impacted third molars. Used on a daily basis in our institution. For study purpose, 10 patients over a period of 1.5 years were selected to participate in the study and rotatory instrument was used for their tooth removal.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. All male and female patients with good general health condition. 2. ASA 1 and 2 patients. 3. Patients able and willing to give their own consent. 4. Patients willing for regular follow up.

ExclusionCriteria

Details

1. Patients with acute infections at surgical site.
2. Patients unable to provide their own consent.
3. Patients with dense sclerotic bone of mandible.
Patients with systemic diseases or hematological conditions such as hemophilia.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

An Open list of random numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Pain	3,7,14 days postoperative

Secondary Outcome

Outcome	TimePoints
Swelling Trismus Paresthesia Time taken	3,7,14 days postoperative

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20"

Phase of Trial

N/A

Date of First Enrollment (India)

04/04/2016

Date of Study Completion (India)

15/11/2017

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Not published as of submission for ctri approval.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Rotatory instruments have long been the device of choice for bone removal during third molar impaction surgeries. However this method causes some amount of local morbidity to the hard and soft tissue structures. Piezotome has been developed as a precise and selective bone cutting method, which causes minimal to nil thermal damage to the bone and is a soft tissue sparing instrument. Hence it lends itself to safe use in less accessible areas such as lower third molar region.

This study was conducted to evaluate the benefits of using piezotome in the extraction of impacted third molars if any, and to establish any significant advantages it might have over the electrical handpiece and bur.

Findings of the study indicated a significantly less amount of postoperative morbidity such as swelling, pain and trismus with the use of piezotome over the rotatory handpiece, which might have some long term benefits for the patient.

Summary- Use of piezotome in ostectomy for third molar extraction was found to cause less swelling, pain and trismus as compared to removal of bone with electrical handpiece and bur.